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Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of Depression

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ClinicalTrials.gov Identifier: NCT01516931
Recruitment Status : Unknown
Verified July 2014 by Huaning Wang, Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : January 25, 2012
Last Update Posted : July 21, 2014
Sponsor:
Collaborators:
The No.3 hospital of PLA
The No.91 hospital of PLA
No. 102 Hospital of Chinese People's Liberation Army
Information provided by (Responsible Party):
Huaning Wang, Xijing Hospital

Brief Summary:
The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of the symptoms of depression. Primary Outcome Measures:Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period. Secondary Outcome Measures: Symptom change as measured by Hamilton Depression Rating Scale (HDRS); Illness severity change as measured by Clinical Global Impression of Severity for depression(CGI-S-DEP); Change in subject functioning using the Personal and Social Performance Scale.

Condition or disease Intervention/treatment Phase
Depression Procedure: repetitive Transcranial Magnetic Stimulation (rTMS) Behavioral: counseling Phase 3

Detailed Description:
Transcranial magnetic stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.Several factors characterize repetitive transcranial magnetic stimulation (rTMS) as a strategic aid in the treatment of depression.Depression is a chronic illness and generally requires life-long treatment. However, up to current days there have been no studies evaluating the effects of rTMS in the maintenance treatment of depression. This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of rTMS, as monotherapy, relative to placebo in delaying the time to relapse in patients with depression. Patients with acute symptoms of depression will be enrolled. The study will consist of 4 periods: an up to 7 days screening/tolerability period, a 6-week open-label flexible dose lead-in period, a 6-week open-label fixed dose stabilization period, and a 12 months double-blind relapse prevention period. The study will consist of 4 phases: a screening/tolerability phase of up to 7 days; an open-label, flexible-dose lead-in phase of 8 weeks; an open-label, fixed-dose stabilization phase of 6 weeks; and a single-blind relapse prevention phase of 12 months. During the open-label phase, all patients will be treated with venlafaxine. Remitterswith Hamilton Rating Scale for Depression [HAM-D17] score ≤ 7will be eligible to enter the single-blind phase and will be randomly assigned to one of three groups: group 1 on active rTMS and venlafaxine; group 2 on sham rTMS and venlafaxine; group 3 on venlafaxine alone. Efficacy will be evaluated during the study using relapse assessment (time between subject randomization to treatment and the first occurrence of relapse). Secondary outcome measures will include: symptom changes, measured by the Hamilton Rating Scale for Depression [HAM-D17]; illness severity changes, measured by the Clinical Global Impression of Severity for Depression (CGI-S-DEP); and changes in subject functioning, assessed with the Personal and Social Performance Scale. Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiography, and measurements of vital signs (temperature, pulse and blood pressure) and weight. Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). A 10 milliliter pharmacogenomic blood sample (sample for DNA research) will be collected from patients who give separate written informed consent for this part of the study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in the Prevention of Relapse of the Symptoms of Depression.
Study Start Date : December 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Venlafaxine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: active rTMS and venlafaxine

rTMS:Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months.

venlafaxine:150-225mg/day

Procedure: repetitive Transcranial Magnetic Stimulation (rTMS)
1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks
Placebo Comparator: sham rTMS and venlafaxine
Sham stimulation will be given at the same site and frequency, using a Magstim sham-coil system. During rTMS, participants will be instructed to keep their eyes open and relax.
Behavioral: counseling
Placebo monthly by general counseling for 12 months.
Placebo Comparator: venlafaxine alone
responders will be maintained on the same effective dose of venlafaxine for the entire duration of the RCT, unless they relapse and will have to exit the protocol and enter a naturalistic follow-up



Primary Outcome Measures :
  1. Time for relapse [ Time Frame: Participants will be followed for the duration of 15 month double-blind Relapse Prevention Period, an expected average of 5 weeks ]
    Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period


Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: baseline and 15 months ]
    Reduction on the scores of HDRS (as on the scores of Depression Scale and Hamilton Anxiety Scale; and improves the global clinical status in Clinical Global Impression, Global Assessment Scale and 36-item Short-form Health Survey - Quality of Life)

  2. Illness severity change [ Time Frame: baseline and 15 months ]
    Illness severity change as measured by Clinical Global Impression of Severity for depression.

  3. subject functioning [ Time Frame: baseline and 15 months ]
    Change in subject functioning using the Personal and Social Performance Scale (PSP)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of depression
  • Experiencing an acute exacerbation of depression symptoms
  • Baseline score of at least 14 points on the Hamilton Depression rating Scale-17 items
  • Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements

Exclusion Criteria:

  • Comprised ferromagnetic metallic implants
  • Pacemakers
  • Previous neurosurgery
  • History of seizures
  • Major head trauma
  • Alcoholism
  • Drug addiction
  • Any psychiatric or neurological disorder other than depression and anxiety
  • Psychotic depression
  • Suicidal propensities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516931


Locations
China, Shaanxi
Qingrong Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Qingrong Tan, M.D    +086-13991325681    tanqingr@fmmu.edu.cn   
Contact: Huaning Wang, Ph.D    +086-13609161341    xskzhu@fmmu.edu.cn   
Principal Investigator: Qingrong Tan, M.D         
Sub-Investigator: Huaning Wang, Ph.D         
Sponsors and Collaborators
Xijing Hospital
The No.3 hospital of PLA
The No.91 hospital of PLA
No. 102 Hospital of Chinese People's Liberation Army

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Huaning Wang, director of department, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01516931     History of Changes
Other Study ID Numbers: Huaning Wang
XijingH ( Other Identifier: XijingH )
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: July 21, 2014
Last Verified: July 2014

Keywords provided by Huaning Wang, Xijing Hospital:
repetitive Transcranial Magnetic Stimulation (rTMS)
Depression
Venlafaxine
Relapse

Additional relevant MeSH terms:
Depression
Depressive Disorder
Recurrence
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs